MediWound Successfully Completes Commissioning of Expanded GMP Manufacturing Facility for NexoBrid®
MediWound (Nasdaq: MDWD) completed commissioning of its expanded GMP manufacturing facility in Yavne, Israel on November 3, 2025, marking a step toward full operational readiness by year-end 2025. The expansion is expected to increase NexoBrid production capacity by approximately sixfold, aiming to support supply across more than 40 approved markets. The company says the facility will enable a scalable, reliable global supply once regulatory reviews are complete. Market availability remains subject to the completion of those regulatory reviews.
MediWound (Nasdaq: MDWD) ha completato la messa in servizio del proprio stabilimento di produzione GMP ampliato a Yavne, Israele, il 3 novembre 2025, segnando un passo verso la piena disponibilità operativa entro la fine del 2025. L'espansione dovrebbe aumentare la produzione di NexoBrid di circa sei volte, con l'obiettivo di supportare forniture in oltre 40 mercati approvati. L'azienda afferma che l'impianto permetterà una fornitura globale scalabile e affidabile non appena le revisioni regolatorie saranno completate. La disponibilità sul mercato resta soggetta al completamento di tali revisioni regolatorie.
MediWound (Nasdaq: MDWD) completó la puesta en marcha de su instalación de fabricación GMP ampliada en Yavne, Israel, el 3 de noviembre de 2025, marcando un paso hacia la plena operatividad para a finales de 2025. La expansión se espera que incremente la capacidad de producción de NexoBrid en aproximadamente seis veces, con el objetivo de respaldar el suministro en más de 40 mercados aprobados. La empresa afirma que la instalación permitirá un suministro global escalable y confiable una vez que se completen las revisiones regulatorias. La disponibilidad en el mercado sigue sujeta al completamiento de dichas revisiones regulatorias.
MediWound (Nasdaq: MDWD)는 2025년 11월 3일 이스라엘 야브네에 위치한 확장된 GMP 제조 시설의 시운전을 완료하며 2025년 말까지 완전한 운영 준비에 한 걸음 더 다가섰습니다. 확장은 NexoBrid 생산 능력을 대략 여섯 배로 늘릴 것이며, 승인된 40개 이상의 시장에서의 공급을 지원하는 것을 목표로 합니다. 회사는 규제 심사가 완료되면 이 시설이 확장 가능하고 안정적인 글로벌 공급을 가능하게 할 것이라고 말합니다. 시장 가용성은 해당 규제 심사의 완료 여부에 달려 있습니다.
MediWound (Nasdaq : MDWD) a achevé la mise en service de son site de fabrication GMP étendu à Yavne, Israël, le 3 novembre 2025, marquant un pas vers une pleine disponibilité opérationnelle d’ici fin 2025. L’expansion devrait augmenter la capacité de production de NexoBrid d’environ six fois, dans le but de soutenir l’approvisionnement dans plus de 40 marchés approuvés. L’entreprise indique que l’installation permettra une offre mondiale évolutive et fiable une fois les révisions réglementaires terminées. La disponibilité sur le marché reste soumise à l’achèvement de ces révisions réglementaires.
MediWound (Nasdaq: MDWD) hat am 3. November 2025 die Inbetriebnahme seiner erweiterten GMP-Fertigungseinrichtung in Yavne, Israel, abgeschlossen und markiert damit einen Schritt in Richtung vollständiger operativer Einsatzbereitschaft bis Ende 2025. Die Erweiterung soll die Produktionskapazität von NexoBrid um etwa sechsfach erhöhen und darauf abzielen, die Versorgung in mehr als 40 genehmigten Märkten sicherzustellen. Das Unternehmen erklärt, dass die Anlage eine skalierbare, zuverlässige globale Versorgung ermöglichen werde, sobald die regulatorischen Prüfungen abgeschlossen sind. Die Marktfähigkeit hängt weiterhin vom Abschluss dieser regulatorischen Prüfungen ab.
ميديوند (بورصة ناسداك: MDWD) أكملت تشغيل منشأة التصنيع GMP الموسعة في يافنيه، إسرائيل، في 3 نوفمبر 2025، مما يمثل خطوة نحو الجاهزية التشغيلية الكاملة بحلول نهاية 2025. من المتوقع أن توسع هذه التوسعة إنتاج NexoBrid بنحو ستة أضعاف، بهدف دعم الإمداد عبر أكثر من 40 سوقاً معتمدة. وتقول الشركة إن المنشأة ستتيح إمداداً عالميًا قابلاً للتوسع وموثوقًا به بمجرد اكتمال المراجعات التنظيمية. تظل توافرية السوق مرهونة بإكمال تلك المراجعات التنظيمية.
- Commissioning completed on November 3, 2025
- Production capacity expected to increase by ~6x
- Targeting full operational readiness by year-end 2025
- Supply aimed for >40 approved markets
- Market availability subject to regulatory review, creating timing uncertainty
MediWound Successfully Completes Commissioning of Expanded GMP Manufacturing Facility for NexoBrid®
Newly commissioned facility marks a significant development toward a sixfold production capacity increase ahead of full operational readiness by year-end 2025
YAVNE, Israel, November 3, 2025 – MediWound Ltd. (Nasdaq: MDWD), a global leader in next-generation enzymatic therapeutics for tissue repair, today announced the successful completion of the commissioning process for its expanded GMP manufacturing facility in Yavne, Israel. This milestone represents an important positive development toward full operational readiness and expanding the Company’s capacity to meet rising global demand for NexoBrid®.
“We are pleased to complete the commissioning of our expanded facility,” said Shmulik Hess, Ph.D., Chief Operating and Commercial Officer of MediWound. “Following regulatory review, we will be well positioned to ensure a reliable, scalable global supply of NexoBrid across more than 40 approved markets. This achievement reflects our team’s dedication to operational excellence and our commitment to providing physicians and patients with timely access to NexoBrid.”
The expanded facility, which is expected to achieve full operational readiness by year-end 2025, will increase production capacity for NexoBrid by approximately sixfold, enabling scalable, reliable supply to meet the product’s growing global demand. Market availability remains subject to the completion of regulatory reviews.
About NexoBrid®
NexoBrid® is a topically administered, biological orphan drug for the enzymatic removal of eschar in patients with deep partial- and full-thickness thermal burns. It selectively removes non-viable tissue while preserving viable tissue and is approved for use in adults and pediatric patients in over 40 countries, including the United States, European Union, and Japan.
About MediWound
MediWound Ltd. (Nasdaq: MDWD) is a global biotechnology company focused on developing and commercializing enzymatic therapies for non-surgical tissue repair. The company’s FDA-approved biologic, NexoBrid®, is indicated for the enzymatic removal of eschar in thermal burns and is marketed in the U.S., European Union, Japan, and other international markets. MediWound is also advancing EscharEx®, a late-stage investigational therapy for the debridement of chronic wounds. EscharEx has demonstrated clinical advantages over the leading enzymatic debridement product and targets a substantial global market opportunity.
For more information, visit www.mediwound.com and follow us on LinkedIn and X (formerly Twitter).
Cautionary Note Regarding Forward-Looking Statements
MediWound cautions you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe, or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties, and factors, all of which are difficult to predict and many of which are beyond our control. Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release. These statements are often, but are not always, made through the use of words or phrases such as “anticipates,” “intends,” “estimates,” “plans,” “expects,” “continues,” “believe,” “guidance,” “outlook,” “target,” “future,” “potential,” “goals” and similar words or phrases, or future or conditional verbs such as “will,” “would,” “should,” “could,” “may,” or similar expressions.
Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, study design, expected data timing, objectives anticipated timelines, expectations and commercial potential of our products and product candidates, including NexoBrid®; the timing and success of operational readiness by year-end 2025, the likelihood to successfully complete the regulatory reviews and our ability to meet global demand. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with market acceptance of NexoBrid; the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of our products and products; our expectations regarding future growth; market acceptance of our products and product candidates; our ability to maintain adequate protection of our intellectual property; the impact of government laws and regulations and the impact of the current global macroeconomic climate on our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of our products and product candidates in the future.
These and other significant factors are discussed in greater detail in MediWound’s annual report on Form 20-F for the year ended December 31, 2024, filed with the Securities and Exchange Commission (“SEC”) on March 19, 2025 and Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time. These forward-looking statements reflect MediWound’s current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law.
MediWound Contacts:
Hani Luxenburg
Chief Financial Officer
MediWound Ltd.
ir@mediwound.com
Daniel Ferry
Managing Director
LifeSci Advisors, LLC
daniel@lifesciadvisors.com
Media Contact:
Ellie Hanson
FINN Partners for MediWound
ellie.hanson@finnpartners.com+1-929-588-2008
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